NDC 68180-478

Simvastatin 10 mg tablet, film coated

On the label: Lupin Pharmaceuticals, Inc..

India: 2

Where it's made

FactoryWhereRoleLast FDA inspection
Lupin LimitedSalcette, IndiaMakes it and packages it Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action
Lupin LimitedPithampur, IndiaMakes it and packages it Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action

Product details

Generic drug
Simvastatin: every company that makes it
Form
tablet, film coated, oral
Strength
10 mg
Approval
ANDA ANDA078103
On the market since
Jun 12, 2007
Package NDCs
68180-478-01 68180-478-02 68180-478-03
Official label
DailyMed (National Library of Medicine), updated Jan 13, 2026

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